A First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4175408, an Antibody Drug Conjugate Targeting Protein Tyrosine Kinase 7-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors
Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The purpose of this study is to measure the safety and efficacy of LY4175408 in participants with selected advanced cancer. In addition, this study will evaluate how much LY4175408 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. Participation could last up to 4 years.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Have one of the following advanced or metastatic solid tumor cancers:
‣ Non-small cell lung cancer (NSCLC)
⁃ Small cell lung cancer (SCLC)
⁃ Endometrial cancer
⁃ Triple negative breast cancer (TNBC) (characterized by HR-negative disease and HER2-negative expression according to American Society of Clinical Oncology (ASCO) - College of American Pathologists guidelines).
• Received all standard therapies for which the individual was deemed to be an appropriate candidate by the treating investigator (except in Cohort B1 and B2 expansion, which require participants who are treatment naive in the advanced metastatic setting); OR the individual is refusing the remaining most appropriate standard of care treatment; OR there is no standard therapy available for the disease.
• Eastern Cooperative Oncology Group (ECOG) performance status of greater than or equal to (≤) 1.
• For dose optimization/dose and expansion cohorts (Cohort A2, Cohort B/C): Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• Cohorts B1/B2: NSCLC with no known actionable genomic alterations. ≤2 prior lines of systemic therapy for advanced or metastatic disease in safety lead-in; no prior systemic therapy in expansion
Locations
United States
California
Stanford Medicine Cancer Center
RECRUITING
Stanford
Florida
Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute
RECRUITING
Orlando
Florida Cancer Specialists - Sarasota
RECRUITING
Sarasota
Illinois
The University of Chicago Medical Center (UCMC)
RECRUITING
Chicago
Indiana
Community Health Network
NOT_YET_RECRUITING
Indianapolis
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Missouri
Washington University
RECRUITING
St Louis
New Jersey
John Theurer Cancer Center At Hackensack UMC
RECRUITING
Hackensack
New York
Columbia University
RECRUITING
New York
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Ohio
The Ohio State University (OSU) Wexner Medical Center
RECRUITING
Columbus
Tennessee
Sarah Cannon Research Institute
RECRUITING
Nashville
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Utah
START Mountain Region
RECRUITING
West Valley City
Virginia
NEXT Virginia
RECRUITING
Fairfax
Other Locations
China
West China Hospital, Sichuan University
NOT_YET_RECRUITING
Chengdu
Shanghai East Hospital, Tongji University
NOT_YET_RECRUITING
Shanghai
Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology
NOT_YET_RECRUITING
Wuhan
France
Centre Leon Berard
RECRUITING
Lyon
Institut Gustave Roussy
RECRUITING
Villejuif
Japan
Kyoto University Hospital
RECRUITING
Kyoto
Cancer Institute Hospital of JFCR
RECRUITING
Tokyo
National Cancer Center Hospital
RECRUITING
Tokyo
Republic of Korea
Samsung Medical Center
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Spain
Hospital Universitario Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact